Evidence map›Paper›PMID 27044332›Full record

Trial reportCardiovascular diabetology2016

Rationale and design of a randomized trial to test the safety and non-inferiority of canagliflozin in patients with diabetes with chronic heart failure: the CANDLE trial.

Atsushi Tanaka, Teruo Inoue, Masafumi Kitakaze, Jun-Ichi Oyama, Masataka Sata, Isao Taguchi, Wataru Shimizu, Hirotaka Watada, Hirofumi Tomiyama, Junya Ako and 11 more

Open access · goldFull text readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular diabetology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
6.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Pooled it
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  8. Article
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  14. Management of Heart Failure with Preserved Ejection Fraction: Current Challenges and Future Directions.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2017
    Review
  15. Review
  16. Progress in the Presence of Failure: Updates in Chronic Systolic Heart Failure Management.Current treatment options in cardiovascular medicine · 2017
    Review
  17. Review
  18. SGLT2 Inhibitors: Benefit/Risk Balance.Current diabetes reports · 2016
    Review
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 17 institutions in 1 country.

Atsushi TanakaDepartment of Cardiovascular Medicine, Saga University, Saga, Japan.
Teruo InoueDepartment of Cardiovascular Medicine, Dokkyo Medical University School of Medicine, Mibu, Japan.
Masafumi KitakazeDepartment of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, Suita, Japan.
Jun-Ichi OyamaDepartment of Advanced Cardiology, Saga University, Saga, Japan.
Masataka SataDepartment of Cardiovascular Medicine, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan.
Isao TaguchiDepartment of Cardiology, Koshigaya Hospital, Dokkyo Medical University, Koshigaya, Japan.
Wataru ShimizuDepartment of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.
Hirotaka WatadaDepartment of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Hirofumi TomiyamaDepartment of Cardiology, Tokyo Medical University, Tokyo, Japan.
Junya AkoDepartment of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
Yasushi SakataDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
Toshihisa AnzaiDepartment of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.
Masaaki UematsuKansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan.
Makoto SuzukiCardiology Department, Kameda Medical Center, Kamogawa, Japan.
Kazuo EguchiDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University, Shimotsuke, Japan.
Akira YamashinaDepartment of Cardiology, Tokyo Medical University, Tokyo, Japan.
Yoshihiko SaitoFirst Department of Internal Medicine, Nara Medical University, Kashihara, Japan.
Yasunori SatoThe Clinical Research Center, Graduate School of Medicine, Chiba University, Chiba, Japan.
Shinichiro UedaDepartment of Clinical Pharmacology & Therapeutics, University of the Ryukyus School of Medicine, Okinawa, Japan.
Toyoaki MuroharaDepartment of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Koichi NodeDepartment of Cardiovascular Medicine, Saga University, Saga, Japan. node@cc.saga-u.ac.jp.
Saga University · JPNational Cerebral and Cardiovascular Center · JPTokyo Medical University · JPChiba University · JPDokkyo Medical University · JPDokkyo Medical University Saitama Medical Center · JPJichi Medical University · JPJuntendo University · JPKameda Medical Center · JPKansai Rosai Hospital · JPKitasato University · JPNagoya University · JPNara Medical University · JPNippon Medical School · JPOsaka University · JPTokushima University · JPUniversity of the Ryukyus · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBecause type 2 diabetes mellitus is associated strongly with an increased risk of cardiovascular diseases, the number of patients with diabetes with chronic heart failure is increasing steadily. However, clinical evidence of therapeutic strategies in such patients is still lacking. A recent randomized, placebo-controlled trial in patients with type 2 diabetes with high cardiovascular risk demonstrated that the SGLT2 inhibitor, empagliflozin, reduced the incidence of hospitalization for heart failure. Because SGLT2 inhibitors cause a reduction in body weight and blood pressure in addition to improving glycemic control, they have the potential to exert beneficial effects on the clinical pathophysiology of heart failure. The aim of the ongoing CANDLE trial is to test the safety and non-inferiority of canagliflozin, another SGLT2 inhibitor, compared with glimepiride, a sulfonylurea agent, in patients with type 2 diabetes mellitus and chronic heart failure.

methodsA total of 250 patients with type 2 diabetes who are drug-naïve or taking any anti-diabetic agents and suffering from chronic heart failure with a New York Heart Association classification I to III will be randomized centrally into either canagliflozin or glimepiride groups (1: 1) using the dynamic allocation method stratified by age (<65, ≥65 year), HbA1c level (<6.5, ≥6.5 %), and left ventricular ejection fraction (<40, ≥40 %). After randomization, all the participants will be given the add-on study drug for 24 weeks in addition to their background therapy. The primary endpoint is the percentage change from baseline in NT-proBNP after 24 weeks of treatment. The key secondary endpoints after 24 weeks of treatment are the change from baseline in glycemic control, blood pressure, body weight, lipid profile, quality of life score related to heart failure, and cardiac and renal function. DISCUSSION: The CANDLE trial is the first to assess the safety and non-inferiority of canagliflozin in comparison with glimepiride in patients with type 2 diabetes with chronic heart failure. This trial has the potential to evaluate the clinical safety and efficacy of canagliflozin on heart failure. Trial registration Unique trial Number, UMIN000017669.

Indexed as

AdultAgedAged, 80 and overBenzhydryl CompoundsBlood GlucoseBlood PressureCanagliflozinChronic DiseaseDiabetes Mellitus, Type 2FemaleGlucosidesHeart FailureHumansHypoglycemic AgentsMaleMetforminBenzhydryl CompoundsBlood GlucoseCanagliflozinempagliflozinglimepirideGlucosidesHypoglycemic AgentsMetforminSulfonylurea CompoundsCanagliflozinChronic heart failureGlimepirideNon-inferiorityNT-proBNPSafetySGLT2 inhibitorType 2 diabetes mellitus

Identifiers

PMID27044332
PMCPMC4820875
OpenAlexW2320548273

What Socratic holds

Textfull text, public
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.